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Completed

NCT Number: NCT03071497

Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX

* In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion. * A successful preoperative treatment of IDA via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. This however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure. * Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect ID. * This study aims to evaluate a prototype device detecting ZnPP non-invasively in the intact oral mucosa of surgical patients. * Results from the non-invasive measurement will be compared to reference measurements of ZnPP from residual blood samples (HPLC analysis) as well as to other parameters including Hb level and iron profile (MCH [= mean corpuscular hemoglobin], MCV [= mean corpuscular volume], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, CRP).

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

About this study

The non-invasive measurements will be performed using a prototype device based on fluorescence spectroscopical techniques. In brief, light (restricted wavelengths: 407 / 425nm) will be used to excite ZnPP molecules within the blood of the oral mucosa by means of an optical fibre prob. The outgoing fluorescence emission of the excited molecules will be analyzed using a spectrometer and converted to a ZnPP value [unit: µmol/mol heme] using mathematical transformations as well as spectral fitting.

This study compares the diagnostic performance of iron deficiency based on non-invasive measurements of Zinc protoporphyrin with results based on standard laboratory procedure (i.e. ZnPP measured in whole blood sample using HPLC) and blood values assessed during clinical routine, respectively.

If results of non-invasive and reference measurement techniques yield coinciding results, the non-invasive method could provide an improved mean to detect iron deficiency and thereby to improve treatment of patients suffering from iron deficiency anemia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years

Exclusion criteria

  • Patients who received a blood transfusion less than 8 weeks before examination
  • Pregnancy

Treatment and study plan

Non-invasive analysis of Zinc protoporphyrin

Diagnostic Test

In patients fitting the inclusion criteria Zinc protoporphyrin will be measured non-invasively as proxy for iron deficiency. Results will be compared to ZnPP reference values measured via HPLC and with spectroscopical measurements performed on whole blood as well as with blood values (HB, MCH, MCV, ferritin, CRP, transferrin saturation, soluble transferrin receptor) assessed during clinical routine.

Primary outcomes

  1. Zinc protoporphyrin blood concentration (non-invasive measurement)

    Time frame: Baseline

    Using the prototype device Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured non-invasively in the oral mucosa.

    Concentrations will be compared (Spearman's Rho, sensitivity, specificity) with Zinc protoporphyrin measurements of whole blood samples (see outcome 2 and 3).

Secondary outcomes

  1. Zinc protoporphyrin blood concentration (HPLC reference measurement)

    Time frame: Baseline

    Using HPLC, the analytical reference method, Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.

  2. Zinc protoporphyrin blood concentration (spectroscopic measurement)

    Time frame: Baseline

    Using fluorescence spectroscopic methods Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.

Other outcomes

  1. Hemoglobin

    Time frame: Baseline

    Hemoglobin levels [unit: g/dL] will be assessed from blood samples using standardized laboratory techniques.

    Hemoglobin levels will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

  2. MCH

    Time frame: Baseline

    MCH (= mean corpuscular hemoglobin) [unit: pg] will be assessed from blood samples using standardized laboratory techniques.

    MCH will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

  3. MCV

    Time frame: Baseline

    MCV (= mean cell volume) [unit: fL = femtoliter] will be assessed from blood samples using standardized laboratory techniques.

    MCV will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

  4. Ferritin

    Time frame: Baseline

    Ferritin [unit: µg/L] will be assessed from blood samples using standardized laboratory techniques.

    Ferritin levels will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

  5. CRP

    Time frame: Baseline

    CRP (= C-reactive protein) [unit: mg/dL] will be assessed from blood samples using standardized laboratory techniques.

    CRP will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

  6. Transferrin saturation

    Time frame: Baseline

    Transferrin saturation [unit: %] will be assessed from blood samples using standardized laboratory techniques.

    Transferrin saturation will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

  7. Soluble transferrin receptor

    Time frame: Baseline

    Soluble Transferrin receptor [unit: mg/L] will be assessed from blood samples using standardized laboratory techniques.

    Soluble transferrin receptor will be compared with non-invasive Zinc protoporphyrin measurements (Spearman's Rho, sensitivity, specificity).

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2017
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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